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Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

NCT ID: NCT02721966

Last Updated: 2020-10-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-03

Study Completion Date

2019-06-26

Brief Summary

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The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

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Detailed Description

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In the anlalysis (CSR), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. So there were 498 participants, and not 503

Conditions

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Axial Psoratic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

498 patients were randomized in this Phase 3b trial. 5 (of 503) were mis-randomized, i.e. received randomization number but never received study medication.

This was a 52-week, randomized, double-blind, double-dummy, placebo-controlled, multicenter study to assess the efficacy of secukinumab 150 mg or 300 mg in patients with AxPsA who had an inadequate response to NSAIDs. The study had 2 treatment periods; a placebo-controlled period from Baseline to Week 12 followed by an active treatment period from Week 12 to Week 52.

At Week 12, patients randomized to placebo at Baseline were re-randomized (1:1) to active treatment with secukinumab 150 mg or secukinumab 300 mg.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AIN457 150mg

Secukinumab dose amount 1 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 1 sc injection every 4 weeks for remaining 44 weeks

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

Anti IL-17a monoclonal antibody

AIN457 300mg

Secukinumab dose amount 2 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 2 sc injection every 4 weeks for remaining 44 weeks

Group Type EXPERIMENTAL

Secukinumab

Intervention Type BIOLOGICAL

Anti IL-17a monoclonal antibody

AIN457 Placebo

Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 150 mg or 300 mg sc injection every 4 week for remaining 40 weeks.

Group Type PLACEBO_COMPARATOR

Secukinumab

Intervention Type BIOLOGICAL

Anti IL-17a monoclonal antibody

Secukinumab and Placebo

Intervention Type DRUG

Placebo matching AIN457

Interventions

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Secukinumab

Anti IL-17a monoclonal antibody

Intervention Type BIOLOGICAL

Secukinumab and Placebo

Placebo matching AIN457

Intervention Type DRUG

Other Intervention Names

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AIN457

Eligibility Criteria

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Inclusion Criteria

* Written informed consent must be obtained before any assessment is performed
* Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
* Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
* Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
* Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period

Exclusion Criteria

* History of exposure to other IL-17 or IL-23 inhibitor biologic drug
* History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
* Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
* Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
* Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Brussels, , Belgium

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Leuven, , Belgium

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Brno, , Czechia

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Bruntál, , Czechia

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Plzen-Bory, , Czechia

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Uherské Hradiště, , Czechia

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Tallinn, , Estonia

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Tartu, , Estonia

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Kuopio, , Finland

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Kuovola, , Finland

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Strasbourg, Cedex, France

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Lyon, , France

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Nantes, , France

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Paris, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Berlin, , Germany

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Bochum, , Germany

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Cottbus, , Germany

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Hamburg, , Germany

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Magdeburg, , Germany

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Athens, , Greece

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Athens, , Greece

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Budapest, , Hungary

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Eger, , Hungary

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Hévíz, , Hungary

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Miskolc, , Hungary

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Veszprém, , Hungary

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Dublin, , Ireland

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Haifa, , Israel

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Kfar Saba, , Israel

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Ramat Gan, , Israel

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Tel Aviv, , Israel

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Bergamo, BG, Italy

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Milan, MI, Italy

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Torino, TO, Italy

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Torino, TO, Italy

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Verona, VR, Italy

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Bologna, , Italy

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Krakow, , Poland

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Piotrkow Trybunalski, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Izhevsk, , Russia

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Kazan', , Russia

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Khanty-Mansiysk, , Russia

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Kursk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Orenburg, , Russia

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Saratov, , Russia

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Yaroslavl, , Russia

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Elche, Alicante, Spain

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Córdoba, Andalusia, Spain

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Terrassa, Barcelona, Spain

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Santander, Cantabria, Spain

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Salamanca, Castille and León, Spain

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Barcelona, Catalonia, Spain

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Lugo, Galicia, Spain

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Santiago de Compostela, Galicia, Spain

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Las Palmas de Gran Canaria, Las Palmas de G.C, Spain

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El Palmar, Murcia, Spain

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A Coruña, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Pontevedra, , Spain

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Seville, , Spain

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Vitoria-Gasteiz, , Spain

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Fribourg, CH, Switzerland

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Basel, , Switzerland

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Sankt Gallen, , Switzerland

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Zurich, , Switzerland

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Devon, Barnstaple, United Kingdom

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Basingstoke, Hampshire, United Kingdom

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Maidstone, Kent, United Kingdom

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Leytonstone, London, United Kingdom

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Bradford, West Yorkshire, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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Hull, , United Kingdom

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Wigan, , United Kingdom

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Novartis Investigative Site

Wolverhampton, , United Kingdom

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Countries

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Belgium Bulgaria Czechia Estonia Finland France Germany Greece Hungary Ireland Israel Italy Poland Romania Russia Spain Switzerland United Kingdom

References

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Baraliakos X, Pournara E, Coates LC, Navarro-Compan V, Blanco R, O'Brien E, Schulz B, Landewe R. Magnetic resonance imaging characteristics in patients with psoriatic arthritis and axial manifestations from the MAXIMISE cohort. Rheumatology (Oxford). 2024 Jan 4;63(1):85-92. doi: 10.1093/rheumatology/kead162.

Reference Type DERIVED
PMID: 37094184 (View on PubMed)

Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D'Angelo S, Schulz B, Rissler M, Nagar K, Perella C, Coates LC. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021 May;80(5):582-590. doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.

Reference Type DERIVED
PMID: 33334727 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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2016-000814-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAIN457F3302

Identifier Type: -

Identifier Source: org_study_id

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